Do You Think The FDA Draft Guidance On Metrics Takes The Industry In The Right Direction?

Source: Life Science Leader

A THE CHALLENGE RESIDES IN FINDING THE RIGHT PREDICTIVE MEASURES that can best prevent problems for industry’s constituents. We know it takes a battery of measures to understand the robustness of operations (e.g., quality management systems, processes, products, and facilities) to ensure fit-for-purpose. Good measures must also evolve as operations change and mature. If our goal is problem prevention, we need predictive measures that are specific to operations that allow us to proactively take action. A majority of the proposed metrics are descriptive (what has happened). These may be able to offer potential correlation to events after the fact. However, appropriate predictive robustness measures will increase the likelihood of problem prevention. Alternatively, let’s consider establishing guidance for an internal measurement program (which could be tailored to the site/company), and make these subject to inspection.

Charlene is the head of quality and technical operations at Shire.